OBJECTIVE: To compare the safety of nelfinavir and nevirapine-based antiretroviral treatment in HIV-1-infected pregnant women. METHODS: In Pediatric AIDS Clinical Trials Group Protocol 1022, 38 antiretroviral-naive pregnant women at 10-30 weeks' gestation were randomized to nelfinavir or nevirapine with zidovudine plus lamivudine. The study was suspended because of greater than expected toxicity and changes in nevirapine prescribing information. The incidence of treatment-limiting hepatic or cutaneous toxicity was compared between groups for all subjects and for the subset with CD4 cell counts greater than 250 cells/microL at study entry. RESULTS:Toxicity was seen in 1 (5%) of 21 subjects randomized to nelfinavir and 5 (29%) of 17 subjects randomized to nevirapine (P = 0.07). Within the nevirapine group, 1 subject developed fulminant hepatic failure and died, and another developed Stevens-Johnson syndrome. The one adverse event associated with nelfinavir occurred in a subject with a CD4 cell count less than 250 cells/microL. All 5 events among subjects with a CD4 cell count greater than 250 cells/microL were associated with nevirapine (P = 0.04). CONCLUSIONS:Continuous nevirapine may be associated with increased toxicity among HIV-1-infected pregnant women with CD4 cell counts greater than 250 cells/microL, as has been observed in non-pregnant women.
RCT Entities:
OBJECTIVE: To compare the safety of nelfinavir and nevirapine-based antiretroviral treatment in HIV-1-infected pregnant women. METHODS: In Pediatric AIDS Clinical Trials Group Protocol 1022, 38 antiretroviral-naive pregnant women at 10-30 weeks' gestation were randomized to nelfinavir or nevirapine with zidovudine plus lamivudine. The study was suspended because of greater than expected toxicity and changes in nevirapine prescribing information. The incidence of treatment-limiting hepatic or cutaneous toxicity was compared between groups for all subjects and for the subset with CD4 cell counts greater than 250 cells/microL at study entry. RESULTS:Toxicity was seen in 1 (5%) of 21 subjects randomized to nelfinavir and 5 (29%) of 17 subjects randomized to nevirapine (P = 0.07). Within the nevirapine group, 1 subject developed fulminant hepatic failure and died, and another developed Stevens-Johnson syndrome. The one adverse event associated with nelfinavir occurred in a subject with a CD4 cell count less than 250 cells/microL. All 5 events among subjects with a CD4 cell count greater than 250 cells/microL were associated with nevirapine (P = 0.04). CONCLUSIONS: Continuous nevirapine may be associated with increased toxicity among HIV-1-infected pregnant women with CD4 cell counts greater than 250 cells/microL, as has been observed in non-pregnant women.
Authors: Charles van der Horst; Charles Chasela; Yusuf Ahmed; Irving Hoffman; Mina Hosseinipour; Rodney Knight; Susan Fiscus; Michael Hudgens; Peter Kazembe; Margaret Bentley; Linda Adair; Ellen Piwoz; Francis Martinson; Ann Duerr; Athena Kourtis; A Edde Loeliger; Beth Tohill; Sascha Ellington; Denise Jamieson Journal: Contemp Clin Trials Date: 2008-09-07 Impact factor: 2.226
Authors: June M McKoy; Charles L Bennett; Marc H Scheetz; Virginia Differding; Kevin L Chandler; Kimberly K Scarsi; Paul R Yarnold; Sarah Sutton; Frank Palella; Stuart Johnson; Eniola Obadina; Dennis W Raisch; Jorge P Parada Journal: Drug Saf Date: 2009 Impact factor: 5.606
Authors: Matthew G Gartland; Namwinga T Chintu; Michelle S Li; Mwila K Lembalemba; Saziso N Mulenga; Maximillian Bweupe; Patrick Musonda; Elizabeth M Stringer; Jeffrey S A Stringer; Benjamin H Chi Journal: AIDS Date: 2013-05-15 Impact factor: 4.177